SCHOTT solutions no. 1/2013 > Pharmaceutical Systems

New Standards in India

SCHOTT opened India’s first fully automated pharmaceutical packaging plant – a strategic move to help its customers to meet their own growth objectives.

Günther Unterholzner

The city of Jambusar is located only about an hour away from Mumbai by plane in the western Indian state of Gujarat. For years, it has played a key role in the development of India’s pharmaceutical industry. SCHOTT, for instance, has been manufacturing high-quality pharmaceutical tubing in Jambusar since 1998. This year, the company again made a strategic move and opened India’s first fully automated pharmaceutical packaging plant here.The new production facility for pharmaceutical packaging located in the immediate vicinity of its existing tubing plant expands SCHOTT Pharmaceutical Systems’ global production network to
5 tubing production sites and 17 primary packaging production sites, two of them being located in India. They are both operated by SCHOTT KAISHA, a joint venture the company entered into together with Kaisha Manufacturers Private Ltd. back in 2008. The Indo-German joint venture already operates a plant in the West Indian city of Daman and therefore knows the market ­extremely well.

Jambusar is not only the first fully automated production facility on the Indian subcontinent, it also meets the requirements defined in the ISO 15378 standard. Photo: SCHOTT/A. Sell

With the new plant, SCHOTT KAISHA will boost its annual production capacity by 50 percent to around 2 billion ampoules, vials, cartridges and syringes and make a significant contribution to the 9 billion units in total that the group manufactures each year. The facility features 20 fully automated production lines for ampoules and 16 for vials. In addition to computer-controlled loading of the lines by robots, sophisticated camera systems are used to perform dimensional and cosmetic quality inspections. This level of accuracy essentially redefines the meaning of the term quality control in India.

Jambusar is not only the first fully automated production facility on the Indian subcontinent, it also meets the requirements defined in the ISO15378 standard. This is a good example of the commitment to manufacturing in accordance with the international GMP (Good Manufacturing Practice) standard that serves as an important guideline for the pharmaceutical industry.

The new plant will also enable SCHOTT to extend its strategic position in the pharmaceutical market even further. Dr. Jürgen Sackhoff, Executive Vice President of the Pharmaceutical Systems Business, says manufacturing close to the market is vital to meeting the diverse needs of the customers.

Photo: SCHOTT/A. Sell

And with a view to India, he adds: ”Our investment in India underscores our commitment to the pharmaceutical business and shows how important this business is to the SCHOTT Group.” The move comes at a time when the Indian pharmaceutical market is enjoying sustained growth. Two main trends are currently driving the domestic industry and will continue to do so in the future: Firstly, the emerging middle class in India expects, and can afford, better healthcare services. Secondly, in order to provide better medical care to more people, the government is supporting both the healthcare system and the pharmaceutical industry with ­approximately $ 640 million. It therefore comes as no surprise that the consultants at PricewaterhouseCoopers predict that the pharma market will be worth $49 billion by 2020. This would mean annual growth of around 14 percent.

In line with the growing market, the quality requirements for pharmaceutical products and production processes also continue to rise. Consequently investments aiming at increasing high-quality packaging capacity become a logical strategic move. This view is also shared by the company’s customers. About 250 of them followed the invitation to celebrate the inauguration of this new model plant for the Indian subcontinent.

Photo: SCHOTT/A. Sell

Strong footprint in pharmerging markets

The company says the main objective behind these investments is to improve its ability to supply high-quality products to the local Indian pharma companies. ”This is really the key to helping the pharmaceutical industry benefit from high growth opportunities,” Sackhoff notes. He then emphasizes two strengths he feels are unique to SCHOTT: a true global footprint and uniform global standards for high quality. This applies to both mature markets and the so-called pharmerging markets. Pharmerging markets have one thing in common: their pharmaceutical sector is experiencing above average growth and their public health programs are ­expanding, along with the populations’ access to medicines.

The new plant in India will also enable SCHOTT to extend its strategic position in the pharmaceutical market even further. Photo: SCHOTT/A. Sell

With respect to the latter, the company has been investing heavily. In fact, its latest investment in India is part of the company’s comprehensive growth program specifically for the pharmerging markets. Some examples: The most recent SCHOTT Xinkang ­Pharmaceutical Packaging joint venture that was founded only last year is also enjoying great success in the important Chinese market. The two facilities here manufacture high-quality ampoules, vials, and cartridges for the local market. In accordance with its philosophy of manufacturing close to the customer, the Mainz-based technology group is also one of the few manufacturers that currently operate a facility in Russia. And, last, but certainly not least, SCHOTT is further expanding its footprint in Southeast Asia through its recent investment in Indonesia, which ramps up production capacity at its plant near Jakarta by 20 percent. By continuing to invest in technology and processes, we are laying the foundation for sustained growth in the years to come already today.

SCHOTT has been a strong supporter of India’s rapidly growing pharmaceutical industry since the onset of economic reforms in the 1990s. The company entered the Indian market by way of an acquisition in the Jambusar district (Gujarat) in 1998 and has developed this plant into a model manufacturing site for pharmaceutical tubing. Today, SCHOTT is the only company that manufactures premium quality customized glass tubing directly in India that meets even the highest international standards. The plant in Gujarat serves as a production hub for the entire Asian region, underpinning SCHOTT’s role as Asia’s leading supplier of special glass tubing. SCHOTT’s customers then convert FIOLAX® into important end products like ampoules, vials or pre-fillable syringes.

With a proven track record of more than 100 years, FIOLAX® is currently the world’s most popular glass tubing for use in producing primary pharmaceutical packaging. Pharmaceutical containers made of FIOLAX® are known around the world for their outstanding chemical resistance, neutrality and impermeability.

To ensure that its high requirements for quality are met, SCHOTT has even developed an information and tracking system for FIOLAX® that provides customers with precise information on important manufacturing, material and quality parameters for every delivery batch they order. All details that relate to the production process are tracked from the very start of production and kept available for a period of ten years starting with the date of manufacturing. With its ”FIOLAX® Academy,” SCHOTT also offers its trade partners a complete technical and scientific customer advisory service for the entire value creation chain. In special training programs, experts provide information on the composition, properties and production of pharmaceutical glass tubing. Besides India, the technology group also manufactures FIOLAX® in Germany, Spain and Brazil in accordance with the same uniform worldwide quality standards. In fact, each year, the company manufactures around one million kilometers of pharmaceutical tubing, 25 times the circumference of the earth.